Pharmaceutical News
Dr. Yen Tzung-Hai: How to prevent tainted medicines when a drug is cheaper than a sweetie

Reported by Su Yuan-He

How can patients have confidence in the quality of drugs when a drug is cheaper than a sweetie?  The recent incident of tainted stomachics has aroused the public’s concerns over drug safety.  Dr. Yen Tzung-Hai, a nephrologist and a specialist in clinical toxicology, reckoned that drugs are less safe than sweeties.  Dr. Yen said frankly that the current drug manufacturing process is full of questions.  As some drugs are cheaper than sweeties, he worried that inferior materials have been used by manufacturers to be consumed by patients.

Dr. Yen said that, according to the Pharmaceutical Affairs Law, drugs can be made from food materials or industrial materials; however, the Act Governing Food Safety and Sanitation stipulates that foods can only be made from food materials.  Therefore, drug manufacturers are able to use industrial materials which have been processed and purified to meet the standard of the Chinese Pharmacopoeia as active ingredients or excipients.

Dr. Yen said that drugs are meant to save lives; but tainted drugs are producing the opposite effects.  Food safety is a concern; but, in comparison, drug safety issue is more worrying.  Dr. Yen suggested tightening up the management.  Food materials can be only used for foods; and industrial materials can only be for industrial use.  He also suggested amending the Pharmaceutical Affairs Law to increase the penalty. 

Responding to the recent incident of tainted stomachics, the authority tried to explain that it is not a breach of law for drug manufacturers to use industrial materials as long as they comply with the Chinese Pharmacopoeia.   Dr. Yen said that the competent authority has never carried out inspection on drug manufacturers and just counts on drug manufacturers’ conscience to assure the quality. 

Furthermore, the MOHW failed to test the questionable ingredients, organic arsenic and inorganic arsenic, in this safety incident. Dr. Yen said that though organic arsenic is not toxic, long term use may affect liver and renal functions and increase the risk of cancer.  Taking too much iron may upset stomach.

This incident of tainted drugs highlights the problem of cheap drugs.  Dr. Yen said that as some drugs are cheaper than sweeties, it is not surprising that some manufacturers use inferior materials to reduce cost.

Dr. Yen pointed out that generic drugs are claimed to have the same effect as the original drugs; but, there is a huge price gap between them.  In order to survive, generic manufacturers may resort to cheap and inferior materials.  As a result, drug safety is sacrificed.

The NHI drug price black hole has long been criticized by the society.  Drug manufacturers’ margins are squeezed by the NHI low price policy and hospitals’ price negotiation power.  Using cheap and inferior materials is not beyond one’s comprehension.   Dr. Yen pointed out that in order to ensure drug safety the TFDA needs to tighten up the management and the NHIA needs to address the problems caused by NHI drug prices.

【Taiwan People News / 2015-05-04】